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    Intravenous sildenafil in the treatment of neonates with persistent ...

    Intravenous sildenafil in the treatment of neonates with persistent ...
    Steinhorn RH(1), Kinsella JP, Pierce C, Butrous G, Dilleen M, Oakes M, Wessel DL. ... OBJECTIVE: To evaluate the safety of intravenous (IV) sildenafil, an inhibitor of cyclic ... Purines/pharmacokinetics; Sildenafil Citrate; Sulfones/ administration ...

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    Seventeen patients (median age 5 months) experiencing postoperative ph were randomized and treated, five with placebo and four each with low-, medium-, and high-dose sildenafil. Ph was confirmed by doppler echocardiogram using the modified bernoulli equation to the peak velocity of tricuspid regurgitation   peak velocity of tricuspid regurgitation (ms) that has been correlated with invasive transcatheter measurements , or pulmonary artery (pa) catheter at baseline. Iv sildenafil was well tolerated, and acute and sustained improvements in oxygenation were noted in those neonates who received the higher infusion doses.

    A double-blind, multicenter, placebo-controlled, dose-ranging, parallel-group trial was conducted. The patients, parents, all clinical staff, and the investigators were blinded to study drug allocation. The minimization approach with biased coin assignment was used for stratification.

    Permitted medications included inotropes, milrinone, and other medication used to treat congestive heart failure. In 4 neonates, sildenafil was stopped due to adverse events. Critically ill children in the postoperative setting may have unpredictable enteral absorption , such that intravenous sildenafil may be more appropriate.

    A fast-acting, pulmonary-selective, easily administered agent that is safe and without a rebound effect is needed. In the first 24 h, 40 of placebo and 17 of sildenafil patients required additional therapy (   0. Baseline echocardiograms were performed to verify the presence of ph.

    The dilution was calculated according to the patients weight such that the assigned concentration (low, medium, or high) was infused at the same rate for all patients of a particular weight so that the staff remained blinded to the study dose. This was an open-label, dose-escalation trial in newborns with pphn and an oxygenation index (oi) 15. In pediatric patients undergoing heart surgery, oral sildenafil attenuated rebound ph after ino withdrawal during the early postoperative period.

    The study was conducted in compliance with the declaration of helsinki and the international conference on harmonisation good clinical practices guidelines. An automated interactive voice response system was used to assign patients to treatment. The study protocol was reviewed and approved by the local institutional ethics committees. Thirty-five neonates survived 1 neonate required extracorporeal membrane oxygenation (ecmo) support. Additional exclusion criteria were occurrence of postoperative complications that resulted in hypoxemia (other than ph) due to lung disease serious postoperative bleeding resulting in hypotension impaired renal function serum creatinine 2.


    Intravenous sildenafil for postoperative pulmonary hypertension in ...


    Nov 11, 2010 ... To evaluate the efficacy and safety of intravenous sildenafil for immediate ... Intravenous sildenafil reduced pulmonary artery pressure and ..... Branzi A, Grimminger F, Kurzyna M, Simonneau G. Sildenafil citrate therapy for ... Steinhorn RH, Kinsella JP, Pierce C, Butrous G, Dilleen M, Oakes M, Wessel DL.

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    Sildenafil, sold as the brand name Viagra among others, is a medication used to treat erectile ... Routes of administration · By mouth (tablets), IV · ATC code.
    Steinhorn Intravenous Sildenafil Viagra Sale A clinical trial was designed to assess the efficacy, safety, Branzi A, Grimminger F. All infants or children aged 0 (34 weeks gestational age) to 17 years undergoing corrective cardiac surgery with a clinical diagnosis of postoperative ph within 48 h of the end of surgery and systolic pap 50 of systolic arterial blood pressure (75 for neonates 28 days) were eligible (fig. This was an open-label, dose-escalation trial in newborns with pphn and an oxygenation index (oi) 15. The exclusion criteria included use of postoperative treatment solely for the purpose of treating or preventing ph, including agents used at relatively high doses for the purpose of deepheavy sedation, such as fentanyl agents used for continued paralysis, such as pancuronium (except when used to manage clinical situations such as open chest or critical airway) alkalinization by methods such as hyperventilation (pco ) infusion vasodilators meeting the criteria for extracorporeal membrane oxygenation (ecmo) receipt of concomitant nitrates or no donors, open-label sildenafil within 48 h prior to surgery or any time postoperatively supplemental arginine, long-acting -blockers, endothelin antagonists (e. The minimization approach with biased coin assignment was used for stratification.
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    Congenital heart disease, pulmonary arterial hypertension, postoperative management, pulmonary vasodilatation children with many forms of congenital heart disease (chd) are prone to develop postoperative elevation in pulmonary vascular resistance (pvr). The research pharmacist or other qualified individual received the randomized treatment assignment and prepared the bolus dose and maintenance infusion. Baseline hemodynamic parameters (in patients with a pulmonary artery, left atrial, andor right atrialcentral venous catheter), inotrope score , and vital signs were measured, and blood samples were collected for serum lactate measurement. Placebo was provided as bags of 5 dextrose in water. In the first 24 h, 40 of placebo and 17 of sildenafil patients required additional therapy (   0.

    The exclusion criteria included use of postoperative treatment solely for the purpose of treating or preventing ph, including agents used at relatively high doses for the purpose of deepheavy sedation, such as fentanyl agents used for continued paralysis, such as pancuronium (except when used to manage clinical situations such as open chest or critical airway) alkalinization by methods such as hyperventilation (pco ) infusion vasodilators meeting the criteria for extracorporeal membrane oxygenation (ecmo) receipt of concomitant nitrates or no donors, open-label sildenafil within 48 h prior to surgery or any time postoperatively supplemental arginine, long-acting -blockers, endothelin antagonists (e. However, when administered enterally, the bioavailability of sildenafil is only about 40 in healthy subjects. In these neonates, oi improved significantly by 4 hours after initiation of sildenafil infusion (24. Thirty-five neonates survived 1 neonate required extracorporeal membrane oxygenation (ecmo) support. To evaluate the safety of intravenous (iv) sildenafil, an inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase, in treating near-term and term newborns with persistent pulmonary hypertension of the newborn (pphn).

    Critically ill children in the postoperative setting may have unpredictable enteral absorption , such that intravenous sildenafil may be more appropriate. Sildenafil was delivered by continuous iv infusion for at least 48 hours and up to 7 days. Iv sildenafil was well tolerated, and acute and sustained improvements in oxygenation were noted in those neonates who received the higher infusion doses. Sildenafil acts by inhibiting phosphodiesterase type 5 (pde5), an enzyme that hydrolyzes intracellular cyclic guanosine monophosphate (cgmp) to 5-gmp. In pediatric patients undergoing heart surgery, oral sildenafil attenuated rebound ph after ino withdrawal during the early postoperative period. A double-blind, multicenter, placebo-controlled, dose-ranging, parallel-group trial was conducted. Three intravenous sildenafil dosage regimens were selected to achieve target sildenafil plasma concentrations of approximately 40, 120, and 360 ngml in the low-, medium-, and high-dose groups, respectively. The study protocol was reviewed and approved by the local institutional ethics committees. Intravenous sildenafil reduced pulmonary artery pressure and shortened time to extubation and intensive care unit stay in children with postoperative ph. Additional exclusion criteria were occurrence of postoperative complications that resulted in hypoxemia (other than ph) due to lung disease serious postoperative bleeding resulting in hypotension impaired renal function serum creatinine 2.

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